In processes of this type, sensors are used which can measure many different process parameters and characteristics at any desired time of the process. These sensors are used only a single time, like the disposable or single-use articles such as containers and pipettes, which are being used more and more frequently to increase the output of such processes, to improve the reliability of production, and to minimize production costs and times. Like single-use articles, they must be free of microorganisms during use, i.e., they must be sterile. A standard method of sterilization is so-called “gamma sterilizing”, i.e., sterilization by means of radioactive gamma radiation.
Gamma radiation involves electromagnetic rays (gamma rays) which are emitted by radionuclides such as cobalt 60 isotopes (60 Co or 60Co) and cesium 137 isotopes (137 Cs or 137Cs). Gamma rays are not decelerated by most materials and can pass through most of the single-use articles used in bioprocesses. Microorganisms such as bacteria, algae, fungi, viruses, etc., are killed by the ionizing radiation as a result of damage to their nucleic acids. Gamma rays, furthermore, are not absorbed by the material and leave no radioactivity behind. Gamma sterilization of single-use articles can be easily controlled in a defined radiation environment and offers the advantage that neither heat, moisture, pressure, nor vacuum acts on the objects to be sterilized. Thus it represents a nonvarying and predictable sterilization method and is advantageous with respect to safety, time, and costs.
A sensor device for detecting physical or chemical characteristics of a liquid is known from, for example US 2003/0227394 A1 and U.S. Pat. No. 6,057,773. The known sensor device comprises a housing, inside of which are a sensor element, a data collection element with a memory and a microcontroller connected to the sensor element for data transmission, a data-exchange device for wireless transmission of the data detected by the sensor element to an external unit, and a power supply unit. The disadvantage of this known sensor device is that it does not offer complex sensor functions, and in addition it comprises components which are not resistant to gamma radiation and is therefore not adapted to the above-described use in biopharmaceutical processes, among others.
It is known from the technology of send-and-receive systems for the automatic and contactless identification and localization of objects and life forms by means of radio waves (RFID) that RFID transponders resistant to gamma rays can be used. An example of an RFID transponder of this type is disclosed in US 2009/0289792 A1. WO 2009/120231 A1 describes a device for the authentication of single-use articles in biopharmaceutical production, which device comprises a gamma radiation-resistant, nonvolatile FRAM memory (Ferroelectric Random Access Memory) on an RFID transponder, wherein the data stored in the FRAM memory remain intact even after the RFID transponder has been sterilized by gamma radiation.